PGR2019-00048
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` Exhibit 2002
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`Arguments Made By Petitioner in PGR2019-00048 and in the District Court Litigation
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`PGR2019-00048
`
`The District Court Litigation
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`“Claims 1-13 Would Have Been Obvious
`Over The Korlym Label, Lee, and FDA
`Guidance.” Pet. at 42.
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`“[A] skilled artisan would have had a
`reasonable expectation that 600 mg could be
`administered safely, even in combination with
`a strong CYP3A inhibitor.” Pet. at 33.
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`“Nor would the 300-mg-per-day dose
`limitation on the Korlym Label have
`discouraged a skilled artisan from titrating the
`dose to 600 mg when used in combination
`with strong CYP3A inhibitors.” Pet. at 35
`
`“That is why the FDA instructed Corcept to
`do a clinical study: ‘to get a quantitative
`estimate of the change in exposure of
`mifepristone following co-administration with
`ketoconazole.’” Pet. at 35-36.
`
`“[A] skilled artisan would have known based
`on the label and Lee that the once-daily 600
`mg dose was reasonably likely to work, and
`the skilled artisan would have been able and
`motivated to test whether the 600-mg dose
`would work by running a clinical DDI study.”
`Pet. at 37.
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`“During prosecution, Corcept effectively
`conceded that the ’214 patent claims were
`prima facie obvious in light of the teachings
`of the Korlym Label.” Pet. at 46-47.
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`“Claims 1-13 are invalid as obvious under 35
`U.S.C. § 103 over the 2012 Korlym Label and
`Lee, optionally in combination with 2006
`FDA guidance.” Invalidity Contentions at
`190.
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`“[A] skilled artisan would have had a
`reasonable—while not absolute—expectation
`that 600 mg could be administered safely,
`even in combination with a strong CYP3A
`inhibitor.” Invalidity Contentions at 194.
`
`“Nor would the 300-mg-per-day dose
`limitation on the 2012 Korlym Label have
`discouraged a skilled artisan from titrating the
`dose to 600 mg when used in combination
`with strong CYP3A inhibitors.” Invalidity
`Contentions at 195.
`
`“That is why the FDA instructed Corcept to
`do a clinical study: ‘to get a quantitative
`estimate of the change in exposure of
`mifepristone following co-administration with
`ketoconazole.’” Invalidity Contentions at
`196.
`
`“[A] skilled artisan would have known based
`on the label and Lee that the once-daily 600
`mg dose was reasonably likely to work, and
`the skilled artisan would have been able and
`motivated to test that hypothesis by running a
`clinical study.” Invalidity Contentions at 197.
`
`“During prosecution, Corcept effectively
`conceded that the ’214 patent claims were
`prima facie obvious in light of the teachings
`of the 2012 Korlym Label.” Invalidity
`Contentions at 203.
`
`“[A]ny clinician familiar with the Korlym
`Drug Approval Package would have known
`that there were not necessarily any concerns
`over toxicity.” See Pet. at 49
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`“[A]ny clinician familiar with the Korlym
`Drug Approval Package would have known
`that there were not necessarily any concerns
`over toxicity.” Invalidity Contentions at 204.
`
`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2002, Page 1
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`PGR2019-00048
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` Exhibit 2002
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`PGR2019-00048
`
`The District Court Litigation
`
`“[T]he FDA fully expected that co-
`administration (at some dose) would be safe
`and effective—it just did not know what
`precise dose that was.” Pet. at 49.
`
`“[T]he FDA fully expected that co-
`administration (at some dose) would be safe
`and effective—it just did not know what
`precise dose that was.” Invalidity
`Contentions at 204.
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`A “clinician would have known that, while
`caution was surely warranted in co-
`administering the drugs, there was nothing
`wrong with titrating the dose above 300 mg.”
`Pet. at 49.
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`A “clinician would have known that, while
`caution was surely warranted in co-
`administering the drugs, there was nothing
`wrong with titrating the dose above 300 mg.”
`Invalidity Contentions at 204.
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`“Corcept’s statement that 300 mg
`mifepristone was unlikely to be effective
`betrays a misunderstanding of the basic idea
`of drug-drug interactions.” Pet. at 53.
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`“[E]ven if a 300-mg-per-day dose of
`mifepristone administered alone were
`insufficient to achieve therapeutic efficacy, it
`would not follow that a 300-mg-day-dose in
`combination with a CYP3A inhibitor would
`be insufficient.” Pet. at 53-54.
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`“Corcept’s point (1)—that 300 mg
`mifepristone was unlikely to be effective—
`betrays a misunderstanding of the basic idea
`of drug-drug interactions.” Invalidity
`Contentions at 206.
`
`“[E]ven if a 300-mg-per-day dose of
`mifepristone administered alone were
`insufficient to achieve therapeutic efficacy, it
`would not follow that a 300-mg-day-dose in
`combination with a CYP3A inhibitor would
`be insufficient.” Invalidity Contentions at
`206.
`
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`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2002, Page 2
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